Dimensional Changes During Early Healing Following Subepithelial Connective Tissue Graft for Root Coverage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Tissue Volume Change
研究概览
简要总结
This is an observational study. The participants in this study will be patients at the Graduate Periodontics Clinic at The Ohio State University who are planning to get a gingival graft to treat their gum recession. Gingival grafts are a common way to treat this recession. The grafting surgery is not part of the study.
The main purpose of this study is to better understand the normal healing of a gum graft. In order to do that, the investigators will take different kinds of measurements.
- It is common for the tissue around the graft to have some swelling after the surgery. The investigators will measure the amount of swelling at different times as the graft heals. This will be done with a digital scanner which is passed over the area.
- A device which measures blood flow will be used to see how new blood vessels are forming. This is also a device which is only passed over the area, so it is not invasive.
- Saliva samples will be taken from around the teeth using sterile paper strips. This fluid will be analyzed for substances related to wound healing.
- Participants will fill out questionnaires about their experience with the graft healing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical (oral) Ohio State University College of Dentistry patient, treatment planned for SCTG procedure
- •Miller Recession Class I, II, or III
- •Teeth; Maxillary or mandibular incisors, canines, pre-molars
- •Gingival Index ≤ 1
- •Plaque Index ≤ 1
- •Able and willing to provide informed consent
- •Able and willing to complete questionnaire
排除标准
- •Carious lesions on the tooth selected for surgical root coverage
- •Taking any medications affecting the gingiva and/or oral mucosa: phenytoin, calcium channel blockers , cyclosporin A, immunostimulants/ immunomodulators
- •Quantitative and/or qualitative defects on host inflammatory cells
- •Organ transplant(s)
- •Type I or II diabetes
- •Currently pregnant or lactating
- •Usage of smokeless tobacco
- •Physical/mental handicap which can interfere with adequate oral hygiene performance
研究组 & 干预措施
Grafting Surgery Recipients
Patients at the Graduate Periodontics Clinic at The Ohio State University who are having a gingival graft done to treat gingival recesssion.
干预措施: Gingival graft surgery to treat gingival recession (Procedure)
结局指标
主要结局
Tissue Volume Change
时间窗: Immediately prior to surgery; immediately after surgery; Day 2 post-surgery; Day 3 post-surgery; Day 7 post-surgery; Day 14 post-surgery; Day 21 post-surgery
3-dimensional digital scans will be taken with an intraoral scanner. Once captured, pre- and post-treatment digital image files will be overlapped and analyzed for dimensional changes in the area of the graft. Using digital software, the investigators will calculate the percentage tissue volume change between each time point, using the post-operative scan as a reference.
Correlation with Graft Exposure
时间窗: Immediately prior to surgery; immediately after surgery; Day 2 post-surgery; Day 3 post-surgery; Day 7 post-surgery; Day 14 post-surgery; Day 21 post-surgery
Surgical approaches for subepithelial connective tissue grafting can vary depending on site anatomical characteristics. The choice is often dictated by the anatomy of the site and the severity of the recession and sometimes by operator preference. For the purpose of this study, exposure of the graft will be analysed as an incidental occurrence as surgical needs dictate whether the graft will be exposed or not.
Inflammatory Cytokines
时间窗: Immediately prior to surgery; immediately after surgery; Day 2 post-surgery; Day 3 post-surgery; Day 7 post-surgery; Day 14 post-surgery; Day 21 post-surgery
Saliva samples will be taken from around the teeth at the surgical site by using sterile paper strips. These will be used to study the release of inflammatory cytokines.
Microvascular blood flow
时间窗: Immediately prior to surgery; immediately after surgery; Day 2 post-surgery; Day 3 post-surgery; Day 7 post-surgery; Day 14 post-surgery; Day 21 post-surgery
Laser Doppler Flowmetry (LDF) is a method of determining the real-time microvascular blood flow in soft tissue. LDF will allow the investigators to measure revascularization of the connective tissue graft and see if the degree of soft tissue dimensional change correlates with LDF measurements at certain time points.
Post-operative Pain and Analgesic Use
时间窗: 2, 3, 7, 14 and 21 days after surgery
A post-operative questionnaire will assess the subjects' post-operative pain using visual analog scales, including the location of the pain. The questionnaires will also assess the frequency and effectiveness of the analgesic prescribed.
次要结局
- Thickness of the Gingival Flap and Graft(Day of surgery)
研究者
Binnaz Leblebicioglu
Professor
Ohio State University